A Trial to Evaluate Safety, Feasibility and Efficacy of Endoscopic Duodenal PEF Therapy

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT05984238
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
28 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PEF therapy using the Endogenex Device — DEVICE
    Investigational product.
  • Semaglutide, 1.0 mg/mL — DRUG
    Already registered medicine for type 2 diabetes
  • Sham procedure — OTHER
    The sham control for the PEF therapy procedure.

Study Details

The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.

Key Dates

First listed
Aug 9, 2023
Start date
Aug 3, 2023
Status verified
Aug 2026
Primary completion
Mar 21, 2025
Completion
May 28, 2026

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: PEF therapy procedure
    Patients receive endoscopic duodenal PEF therapy, which is performed using the Endogenex device. After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started.
  • Sham Comparator: Sham procedure
    Patients receive sham procedure, this consists of placing an Endogenex catheter, or a catheter with a similar circumference at the endoscopists discretion in the stomach and leaving it in place for 30 minutes. After which a 2 week isocaloric diet is followed, and then semaglutide, a GLP-1 receptor agonist is started

Primary Outcome Measure

Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety] [ Time Frame: 24 weeks ]

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